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OBJECTIVE: The purpose of this study was to define the maximum tolerated dose (MTD) of topotecan given as escalating doses combined to a fixed dosage of carboplatin in late relapsing ovarian carcinomas. METHODS: Women with relapsing ovarian cancer more than 6 months after first-line treatment were eligible for the study. In the first phase of the trial, patients were allocated to escalating topotecan doses with a carboplatin fixed dose (AUC 5, according to Cockcroft's formula). If no "severe" adverse event occurred in 1 or more of the patients, the topotecan dose was increased. The starting dose of topotecan was 0.50 mg/m(2)/day, for 3 consecutive days, and the dose step was of 0.25 mg/m(2)/day, till 1.5 mg/m(2)/day. The study progressed then in a phase II trial. RESULTS: A total of 39 patients entered the trial. Twenty took part in the escalating topotecan dose phase (4 per dose level, 0.50, 0.75, 1, 1.25, and 1.50 mg/m(2)/day) and 19 in the phase II. No severe adverse event was observed in the phase I of the trial, so the MTD was not reached. In the phase II trial topotecan was given to 1 mg/m(2)/day. Overall grade 3-4 neutropenia, lasting 7 days or less, was observed in 58.9% (23 patients). Thrombocytopenia occurred in 30.8% (12 patients) and grade 3 anemia in 25.6% (10 patients) of subjects. No life-threatening event occurred. Platelets or red blood cell transfusions were given in three cases (7.8%). CONCLUSIONS: This daily-times-3-day schedule of topotecan in combination with carboplatin is safe.

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In recurrent ovarian cancer secondary surgery may be an important opportunity to improve survival and quality of life. In order to give a general overview of the available evidence, we discuss published data on the role of secondary surgery in relapsing ovarian cancer. The median survival after secondary surgery has been reported ranging from 16 to 29 months, and seems to be longer in subjects with optimal debulked disease. However, as with front-line debulking, it is difficult to establish whether the secondary debulking itself has a therapeutic, or even a lasting palliative effect, or whether the patients in whom the procedure is successful are those who have more indolent disease. Any benefit of treatment must be compared with potential morbidity. Post-operative complications are reported in about 25--30% of cases, with a potential impact on hospital stay. During the natural course of the disease, most patients with ovarian cancer develop intestinal obstruction, without impairment of other vital organs or pain. Reported series have suggested that palliative surgery for bowel obstruction is generally feasible in most patients. Some prognostic factors have been suggested to identify patients likely to benefit most from palliative surgery: young age seemed to be associated with longer survival after successful surgery for bowel obstruction, though this finding was not statistically significant. The site of obstruction does not seem to be related to survival after surgery.

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BACKGROUND: In order to analyze the prognostic role of node involvement in advanced ovarian cancer, we have analyzed data from a randomized clinical trial on advanced ovarian cancer. METHODS: Cases were 456 women who entered a randomized multicentric clinical trial comparing two cisplatin-based schemes of treatment after cytoreductive surgery for advanced stage III-IV ovarian cancer. They underwent selective pelvic and/or paraortic lymphadenectomy. RESULTS: A total of 161 (35.3%) cases had positive nodes. The frequency of positive nodes was statistically significantly higher in FIGO stage IV than in stage III. Also grade 3 tumors were more likely to have positive nodes than grade 1-2 tumors. No association was observed between nodal status and response to chemotherapy. The 3-year survival was 46.2 (standard error (SE) = 3.4 based on 147 deaths) and 44.6 (SE = 4.4, based on 84 deaths), respectively, in negative and positive node groups. The corresponding values, when the analysis was performed considering only subjects with residual tumor <1 cm or absent, after first-line cytoreductive surgery were 66.2 (SE = 5.7) and 62.4 (SE = 9.6). CONCLUSIONS: We did not find any association between nodal status and survival. Particularly, nodal status was not a prognostic factor for survival in the subgroup of women with residual tumor <1 cm or absent after cytoreductive surgery.

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Survival and prognostic factors were analysed in 150 patients with histologically confirmed epithelial ovarian cancer stage IA-IIA. The relapse-free and overall survival rates were, respectively, 81% and 88% after 3 and 74% and 84% after 5 years. The analysis of various prognostic factors indicates as the main factor the grade differentiation of the tumour.

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We conducted a phase I-II study with escalating paclitaxel doses plus carboplatin at a fixed dose for previously untreated patients with advanced ovarian cancer in order to define the maximum tolerated dose. Eligible for the study were women with a histologically confirmed diagnosis of ovarian cancer stage III-IV according to the FIGO classification. In the first phase of the study, 6 patients were allocated escalating paclitaxel doses with fixed-dose carboplatin in order to establish the maximum tolerated dose. The starting dose of paclitaxel was 150 mg/m2 given after carboplatin (300 mg/m2) every 4 weeks for a total of six courses. The paclitaxel dose step was 25 mg/m2 up to 250 mg/m2. The study then progressed to a phase II trial using the maximum tolerated paclitaxel dosage reached during the escalating dose phase. A total of 27 patients entered phase I and 23 phase II. Neurotoxicity was observed in 47 patients (94%; 29 grade 1, 17 grade 2, 1 grade 3, according to the WHO classification). The intensity of neurotoxicity tended to be dose related: out of the 15 patients who received < or = 200 mg paclitaxel, a total of 14 grade 1, but no grade 2 or 3 neurotoxicities, were observed. The frequency of grade 1, 2 and 3 neurotoxicity was 15, 17 and 1, respectively, in the 35 women who received > or = 225 paclitaxel +300 mg carboplatin. There was no clear relationship between median WBC and platelet nadir and dose level. Among other toxicities, alopecia was observed in all 50 cases, hypersensitivity in two (4%) and myalgia in 41 (82%; 34 grade 1 and 7 grade 2). These frequencies tended to increase with the dose, but the relationship was not statistically significant. The overall response rate was 78% (39/50) with a complete response rate of 62% (31/50). In conclusion, this study suggests that carboplatin and paclitaxel can be administered safely to patients with advanced ovarian carcinoma. The maximum dose reached was 250 mg/m2 paclitaxel and 300 mg/m2 for carboplatin, but from a clinical point of view the maximum paclitaxel dose we would consider safe is 225 mg/m2.

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A dose-finding study involving 27 untreated patients with ovarian cancer was performed to define the maximum tolerated dose of a 3-hour infusion of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) combined with a fixed dose of carboplatin. The median age of the study patients was 55 years (age range, 30 to 74 years), the median Eastern Cooperative Oncology Group performance status was 0 (range, 0 to 2), and residual tumor to first surgery was > or = 1 cm in 14 patients and less than 1 cm in 13 patients. All patients received carboplatin at a fixed dose of 300 mg/m2 over 1 hour. Paclitaxel was administered at five dose levels starting at 150 mg/m2 and increasing in 25-mg/m2 increments to 250 mg/m2. In the absence of toxicity, courses were repeated every 4 weeks for a total of six cycles. World Health Organization grade 1 hypersensitivity and cardiotoxicity were observed in 7.4% and 14.8% of patients, respectively. Moderate peripheral neuropathy was experienced by 29.6% of patients. Grades 3 and 4 neutropenia lasted less than 7 days; no patient required hospitalization for sepsis or febrile neutropenia, and no supportive treatment with granulocyte or granulocyte-macrophage colony-stimulating factor was needed. The maximum tolerated paclitaxel dose was not achieved.

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We analyzed the relation between reproductive history and risk of uterine fibroids using data from a case-control study. Cases were 621 women with histologically confirmed diagnosis of uterine fibroids. Controls were 1,051 non-hysterectomized patients. Compared with nulliparae, parous women had a relative risk (RR) of fibroids of 0.5 [95% confidence interval (CI) = 0.4-0.6], and the risk declined with number of births. The risk of fibroids also decreased with number of induced abortions (RR = 0.8 and 0.6 for women reporting one or two or more abortions, respectively). A total of 24 cases (3.9%) and 19 controls (1.8%) reported a history of infertility (RR = 2.0; 95% CI = 1.1-3.7).

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BACKGROUND: The purpose of the study was to analyze the determinants of long term survival in women with advanced ovarian cancer and negative second-look laparotomy. METHODS: A series of 140 advanced (Stage III-IV) ovarian cancer patients (median age, 54 years; range, 22-74 years) with negative second-look laparotomy after primary surgery and chemotherapy is included in the analysis. At first diagnosis, all patients were treated with radical or debulking surgery. After primary surgery, the patients were treated with a chemotherapy regimen based on cisplatin or carboplatin alone or in combination with other drugs. All second-look laparotomies were performed 6-8 months after first surgery. RESULTS: The overall survival rates were 76% at 3 years, 66% at 5 years, and 51% at 8 years. The corresponding rates for disease free survival were 57, 50, and 43%, respectively. Survival rates were better for women with a residual tumor 1 cm or less after primary surgery. The 5-year probability of survival was 78% in this group, compared with 55% in women with a residual tumor more than 1 cm (log rank test, P < 0.05). Survival rates for women with tumor Grade 3 tended to be worse than Grades 1-2, but the difference was only of borderline statistical significance. No relationship emerged between survival and age, histotype, and presence of ascites at diagnosis. Women with a residual tumor 1 cm or less and positive lymph nodes had a 66% 5-year probability of survival, compared with 85% for women with a residual tumor 1 cm or less and negative lymph nodes. This difference was significant (log rank test, P = 0.05). The 5-year survival probabilities were 47 and 58%, respectively, in women with a residual tumor more than 1 cm and positive or negative lymph nodes. CONCLUSIONS: This analysis shows a favorable long term survival rate for women with advanced ovarian cancer and complete pathologic response after debulking surgery and postoperative chemotherapy. It further suggests that lymph nodal status is a prognostic factor for women with minimal residual tumor after surgery.

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We considered 49 patients suffering from urinary stress incontinence, operated from January 1984 to December 1989 by Marshall-Marchetti modified after Symmonds procedure. 13 patients had one or more previous surgical procedures. We made urodynamic preoperative tests and a stress test (after Ferrari) in all our cases. We obtained: complete recovery in 80% of our cases, improvement in 14% and failure in 6%; particularly the recovery percentage in our patients operated for the first time was the 97.2%; in the recurrences we had complete success in 46%, an improvement in 38.5% and surgical failure in 15.5%. Complications were observed in 1 patient affected by pubic osteitis, treated with medical therapy. Only 3 patients had an incomplete bladder emptying one year after the surgical operation, with value of the post micturitional residual volume of about 1/3 of the maximal cystometric capacity.

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The efficacy of defibrotide and calcium heparin in the prevention of Deep Vein Thrombosis (DVT) in gynecological surgery were compared in a randomized study. Seventy patients candidate to gynecological surgery (for benign conditions) and 50 candidate to surgery for malignancies were randomly allocated either to defibrotide (400 mg b.i.d. IM from the day before operation to the 7th postoperative day, n = 60) or to calcium heparin (5000 IU t.i.d. SC from the operation to the 7th postoperative day, n = 70). The diagnosis of DVT was made with impedance plethysmography and if necessary confirmed with phlebography. No patient developed established DVT in either groups and no adverse reactions were observed. These results indicate that defibrotide may be considered as an alternative to heparin in the DVT prophylaxis in gynecological surgery.

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Colpocystoproctography is an X-ray investigation that uses radio-opaque material to highlight the bladder and urethra, vaginal canal and rectum. Twenty-five patients (7 suffering from SUI, 7 operated on for SUI and cured, 7 operated on for SUI with relapse, 4 suffering from prolapse without SUI) were submitted to this X-ray examination so as to determine mutual space relations within the pelvic viscera and the efficiency of their support mechanisms. The following parameters were examined: the anterior angle, the urethro-pelvic angle, the vagino-pelvic angle, the ano-rectal angle, the pubo-vesical distance and the position of the vesical neck with respect to the subpubic margin, in three different pictures recorded at rest, during voluntary contraction of the pelvic floor and in the contrary condition of increase in abdominal pressure. The purpose of the study is to see which data provide useful clinical indications in the pre- and post-operative stages in patients with SUI. The extreme variability of the data under dynamic conditions limits the usefulness of the X-rays taken with the pelvic floor at rest. It can be stated that the anterior angle (a.v. 30 degrees) expresses the anatomic condition of the vesical neck supports; the vagino-pelvic angle (a.v. 106 degrees) is an indicator of the support function of the vaginal walls with respect to the cervico-trigonal region, while good elevation on the neck of the bladder and its closeness to the posterior side of the pubic bone are necessary for complete cure. Colpocystoproctography may therefore represent an important diagnostic tool for assessing what operation is available today as the most suitable for correcting the anatomic defect.

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